Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate

QuidelOrtho

Pencoed, United Kingdom

Your New Role:

As a Senior Regulatory Affairs Associate your primary responsibility will be to support the day-to-day regulatory affairs base business operations and new product development (NPD) projects within the Regulatory Affairs department in the Clinical Laboratories business units.

You will, with minimal oversight, manage and oversee the coordination, compilation and submission of regulatory applications to health authorities.

What you’ll be doing:

• Provide regulatory support across Clinical Laboratory product lines.
• Represent RA function for Lifecycle management and NPD Project Teams for reagents (i.e. assays, calibrators, controls, etc),
• Support regulatory base business activities, such as Notified body submissions, Labelling and Change Management reviews (e.g., Change Requests, Change Notices) for regulatory impact.
• Support New product development teams throughout the development phases including generation and management of Regulatory Plans/Strategies, generation of FDA Class II/III Regulatory submissions, supporting the International Regulatory Affairs team.
• Supporting the coordination, compilation and submission of regulatory applications to International regulatory agencies. Interact with agency and Regional QRC personnel to expedite pending applications, resolve regulatory matters and manage development meetings for regulatory submission.
• Administrative activities related to maintaining compliant regulatory status for currently marketed products, which includes the maintenance of technical files, design history files, review and approval of labelling and promotional materials and regulatory assessment of change.
• Interpret regulatory requirements and determine strategy to obtain registrations. Independently make decisions regarding work processes or operational plans and schedules to achieve department objectives. Provide guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes.
• Support any manufacturing site relocations.

What you’ll need to succeed:

• Bachelor’s degree in a Scientific or related field, or previous relevant experience within a regulatory/quality based role.
• Minimum 3 years’ experience in an FDA and or EU (IVDR) Regulated Medical Device or Pharmaceuticals Industry required, IVD Industry experience preferred
• Excellent interpersonal, teamwork and verbal/written communication skills are required.
• Good organizational skills and an ability to manage multiple tasks/projects/priorities.
• The ability to work with business partners across geographies and time zones is critical.
• Experience supporting Regulatory strategies and product development programs.
• Experience should consist of either direct submission of 510(k) and/or BLA applications or EU Notified Body applications for IVD products or biological drug products.
• Experience with Combination product regulations is desired.